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    Summary
    EudraCT Number:2011-003412-23
    Sponsor's Protocol Code Number:V00251IV2024A
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2011-12-23
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2011-003412-23
    A.3Full title of the trial
    EFFECT OF V0251 IN ACUTE VERTIGO.
    A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.
    EFECTO DE V0251 EN EL VÉRTIGO AGUDO.
    ESTUDIO ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFECT OF V0251 IN ACUTE VERTIGO.
    A RANDOMISED DOUBLE-BLIND PLACEBO CONTROLLED STUDY.
    EFECTO DE V0251 EN EL VÉRTIGO AGUDO.
    ESTUDIO ALEATORIZADO, DOBLE CIEGO Y CONTROLADO CON PLACEBO
    A.4.1Sponsor's protocol code numberV00251IV2024A
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPierre Fabre Médicament - IRPF
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportPierre Fabre Medicament
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPharmanet/I3
    B.5.2Functional name of contact pointFabienne Lekaim
    B.5.3 Address:
    B.5.3.1Street AddressI3 Star House 20 Grenfell Road
    B.5.3.2Town/ cityMaidenhead
    B.5.3.3Post codeSL6 1EH
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number0033650093505
    B.5.5Fax number0033975613243
    B.5.6E-mailfabienne.lekaim@i3global.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameN-acetyl-L-leucine
    D.3.2Product code V0251
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.9.1CAS number 1188-21-2
    D.3.9.2Current sponsor codeV0251
    D.3.9.3Other descriptive nameN-acetyl-L-leucine
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    V0251 is a new antivertiginous agent which is being developed for the treatment of symptomatic vertiginous crisis.
    V0251 es un nuevo antivertiginoso que está en desarrollo para el tratamiento de las crisis de vértigo sintomáticas
    E.1.1.1Medical condition in easily understood language
    Symptomatic vertiginous crisis (Acute vertigo)
    Crisis de vértigo sintomáticas ( vértigo agudo)
    E.1.1.2Therapeutic area Diseases [C] - Ear, nose and throat diseases [C09]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10047340
    E.1.2Term Vertigo
    E.1.2System Organ Class 10013993 - Ear and labyrinth disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the study is to determine the efficacy of one single intravenous injection of 4g of V0251 on vertigo symptoms relief in patient presenting with an attack of acute vertigo from vestibular origin.
    El objetivo principal del estudio es determinar la eficacia de una dosis de 4 g de V0251 administrado por vía intravenosa en el alivio de los síntomas del vértigo en pacientes que presentan una crisis de vértigo agudo de origen vestibular
    E.2.2Secondary objectives of the trial
    The secondary objective is to determine the tolerance of 4g of V0251 administered by intravenous route in a single injection.
    El objetivo secundario es determinar la tolerabilidad de 4 g de V0251 administrado por vía intravenosa
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Age 18 to 70 years, included
    - Acute vertigo attack due to vestibular disorder that began within 48 hours before the inclusion
    - Vertigo sensation lasting more than 20 min
    - At least one vertigo symptom of strong intensity (?3 on the VAS ranging 0-4) on the intensity vertigo scale (see section 17.4 for details) at the moment of the inclusion
    - For woman of child bearing potential: negative urine or serum pregnancy test at inclusion and using an efficient contraceptive (surgical or hormonal birth control or intra-uterine device) for at least 2 months before the study and one month after the end of the study, in order to avoid pregnancy while being exposed to the study treatment
    - Able to understand the protocol and having signed the written Informed Consent Form. In case of intense vertigo, the informed consent may be signed by a third party (a trustworthy person except an investigator?s team representative or a sponsor representative) after oral consent of the patient, the Informed Consent Form then being signed by the patient before the end of the study.
    - Likely to be compliant during the study, in the judgement of the investigator
    - Affiliated to the social security system, or is a beneficiary, if applicable in national regulation
    Edad comprendida entre 18 y 70 años, ambos inclusive
    - Crisis de vértigo agudo debido a un trastorno vestibular que comenzó en las 48 horas anteriores a la inclusión
    - Sensación de vértigo que dura más de 20 minutos
    - Al menos un síntoma de vértigo de intensidad fuerte (?3 en la escala analógica visual de 0-4) en la escala de intensidad del vértigo (ver sección ?Criterios de evaluación?) en el momento de la inclusión
    - Para mujeres en edad fértil: prueba de embarazo en orina o suero negativa en la inclusión y que utilicen un anticonceptivo eficaz (esterilización quirúrgica o anticonceptivos hormonales o dispositivo intrauterino) durante al menos 2 meses antes del estudio y un mes después de finalizar el estudio, para prevenir el embarazo mientras esté expuesta al tratamiento del estudio
    - Capaz de entender el protocolo y haber firmado el documento de consentimiento informado por escrito. En caso de vértigo intenso, una tercera persona (una persona de su confianza que no sea un representante del equipo del investigadorInvestigador o un representante del promotorPromotor) podrá firmar el documento de consentimiento después de que el paciente haya otorgado su consentimiento oral, y posteriormente el paciente deberá firmar el documento de consentimiento antes de finalizar el estudio
    - Es probable que cumpla con las instrucciones durante el estudio, en la opinión del investigadorInvestigador
    - Afiliado o beneficiario del sistema de seguridad social, si procede, conforme a la normativa nacional
    E.4Principal exclusion criteria
    Relating to pathologies:
    - Signs of brain, brainstem and/or cerebellar dysfunction (e.g. perioral hypoesthesia, facial paresis/palsy, dysphagia, dysarthria, limb paresis and/or hypoesthesia, coordination deficit, confusion/loss of consciousness)
    - Concomitant central neurological disorder that may involve vertigo or dizziness (e.g. multiple sclerosis, epilepsy, Parkinson?s disease, Arnold-Chiari?s disease, Wallenberg?s disease)
    - Psychogenic vertigo (e.g. vertigo associated with an evident psychiatric disease, postural phobic vertigo, vertigo induced by a conflict or a stress situation, simulation)
    - Patient with history of hypersensitivity to acetylleucine or excipients
    - Narrow angle glaucoma
    - Moderate to severe prostatic hypertrophy or bladder neck obstruction
    - Any medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize his / her health.
    Relating to treatments:
    - Use of ototoxic drugs causing vertigo or dizziness (gentamicin, streptomycin, quinine, mefloquine, methotrexate) within the last month
    - Use of acetylleucine within the last 3 months
    - Use of the following medications from the onset of symptoms, except if the dosage had been stable for at least 3 months:
    - Antihistamines: diphenhydramine, cyclizine, dimenhydrinate, meclozine, hydroxyzine, promethazine
    - Calcium antagonists: cinnarizine, flunarizine
    - Central antidopaminergics : phenothiazines, thioxanthenes, butyrophenones, benzamides, diazepines, oxazepines, aripiprazole, pimozide, risperidone
    - Peripheral antidopaminergics: metoclopramide, alizapride
    - Histaminergics: betahistine
    - Anticholinergics: scopolamine (hyoscine), homatropine
    - GABA agonists: gabapentin, pregabalin
    - Ondansetron
    - Piribedil, piracetam, trimetazidine, ginkgo biloba
    - Acetazolamide
    - Oral steroids
    - Use of antiepileptic drugs (except GABA agonists if the dosage had been stable for at least 3 months)
    Relating to the population:
    - Is a family member or work associate (secretary, nurse, technician,?) of the Investigator
    - Is pregnant or in post-partum period or a nursing mother
    - Has received treatment with known persistent effects or undergone investigation liable to interfere with the present clinical trial
    - Mentally unable to understand the nature, objectives and possible consequences of the trial; or refusing its constraints
    - Has forfeited his / her freedom by administrative or legal award or is under guardianship
    Criterios relacionados con patologías
    - Signos de disfunción cerebral, del tronco encefálico y/o cerebelosa (p. ej.: hipoestesia perioral, paresia/parálisis facial, disfagia, disartria, paresia y/o hipoestesia de las extremidades, falta de coordinación, confusión/pérdida de conocimiento)
    - Trastorno neurológico central concomitante que puede incluir vértigo o mareos (p. ej.: esclerosis múltiple, epilepsia, enfermedad de Parkinson, enfermedad de Arnold-Chiari, enfermedad de Wallenberg, etc.)
    - Vértigo psicogénico (p. ej.: vértigo asociado a una enfermedad psiquiátrica manifiesta, vértigo fóbico postural, vértigo inducido por un conflicto o una situación de estrés, simulación, etc.)
    - Paciente con historia de hipersensibilidad a la acetil-leucina o a los excipientes
    - Glaucoma de ángulo cerrado
    - Hipertrofia prostática de moderada a severa u obstrucción del cuello de la vejiga
    - Cualquier antecedente médico de enfermedad médica o psiquiátrica importante o cirugía que, en opinión del investigadorInvestigador, pudiera poner en peligro la salud del paciente.
    ? Criterios relacionados con tratamientos
    - Uso de medicamentos ototóxicos que producen vértigo o mareos (gentamicina, estreptomicina, quinina, mefloquina, metotrexato) en el último mes
    - Uso de acetil-leucina en los últimos 3 meses
    - Uso de los siguientes medicamentos desde el inicio de los de síntomas, salvo que la dosis haya sido la misma durante al menos 3 meses:
    Antihistamínicos: difenhidramina, ciclizina, dimenhidrinato, meclozina, hidroxizina, prometazina
    Antagonistas del calcio: cinarizina, flunarizina
    Antidopaminérgicos centrales: fenotiazinas, tioxantenos, butirofenonas, benzamidas, diazepinas, oxazepinas, aripiprazol, pimozida, risperidona
    Antidopaminérgicos periféricos: metoclopramida, alizaprida
    Histaminérgicos: betahistina
    Anticolinérgicos: escopolamina (hioscina), homatropina
    Agonistas GABA: gabapentina, pregabalina
    Ondansetrón
    Piribedil, piracetam, trimetazidina, ginkgo biloba
    Acetazolamida
    Corticoesteroides orales
    - Uso de antiepilépticos (salvo agonistas GABA si la dosis ha sido la misma durante al menos 3 meses)
    ? Criterios relacionados con la población
    - Es familiar o tiene una relación laboral (secretaria, enfermera, técnico, etc.) con el investigadorInvestigador
    - Está embarazada o en periodo posparto o está en periodo de lactancia
    - Ha recibido tratamiento con efectos persistentes remanentes conocidos o ha participado en una investigación que probablemente interfiera en este ensayo clínico
    - Mentalmente incapaz de entender la naturaleza, objetivos y posibles consecuencias del ensayo; o no acepta las restricciones del ensayo
    - Ha perdido su derecho a la libertad por orden judicial o administrativa o está legalmente incapacitado
    E.5 End points
    E.5.1Primary end point(s)
    Mean Vertigo Score (VSM)
    Puntuación de vértigo media (PVM)
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 min
    30 minutos
    E.5.2Secondary end point(s)
    -VSM
    - Mean Concomitant Symptom Score (CSSM)
    PVM
    Puntuación de síntomas concomitantes media (PSCM)
    E.5.2.1Timepoint(s) of evaluation of this end point
    2 and 4 hours
    2 a 4 horas
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Israel
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Last visit of the last patient
    La última visita del último paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months9
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 119
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 13
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state32
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 115
    F.4.2.2In the whole clinical trial 132
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard care/Provided in the protocol
    Práctica clínica habitual/Proporcionado en el protocolo
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2012-04-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-02-15
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-04-15
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